Abstract
Effective clinical trials depend on the production of scientifically sound data. Clinical research coordinators monitor various activities to assure that data meet standards for timeliness and quality. Traditional methods of assuring data quality are less than optimal because they are based on correcting mistakes after they occur. Because they are focused on problem prevention, the techniques of continuous quality improvement represent a more effective means of maintaining high quality of data. This article describes the means by which principles of continuous quality improvement were incorporated into an HIV/AIDS clinical research network, as well as outcomes associated with these efforts.
The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) is a national clinical trials program sponsored by the Division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID). The CPCRA was established in 1989 to broaden the scope of the AIDS research effort of NIAID to include clinical trials conducted in community-based settings. The CPCRA includes 15 research units located throughout the United States that together have enrolled more than 25,000 HIV-infected patients in clinical trials. These units collaborate with more than 160 primary care sites in private physicians' practices, public hospital clinics, community clinics, university and Department of Veterans Affairs hospital clinics, and drug treatment facilities. CPCRA investigators test new therapies and treatment strategies in a large group of patients whose demographics reflect those of the current HIV/AIDS epidemic in the country. Data from these trials are collected and analyzed centrally at the Statistical and Data Management Center at the University of Minnesota.
CPCRA trials have demonstrated that community-based research can generate high-quality, scientifically sound data in a timely and effective manner. The excellence of CPCRA data can be attributed, in part, to quality improvement measures that include: patient appointment reminders, education and training for CPCRA research staff and for patients, data assessment and peer support activities provided by the CPCRA's Quality Improvement Committee, and each research unit's local data quality improvement plans. The use of these measures evolved as part of the Committee's adoption of the principles of continuous quality improvement (CQI) a systematic approach to process improvement used successfully by many different types of organizations.1 The focus of this article is the application of some of the key CQI principles and methods in the conduct of clinical research in the CPCRA.